Nouvelle déclaration d'incident
No de la demande: 2017-0527
Numéro de référence du titulaire d'homologation: 2017KP036
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-144
Nom du produit: k9 advantix II extra large dog
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Great Dane
1
Femme
Inconnu
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
The dog was bathed on unknown dates in 2013, approximately every 3 days, with a medicated pet shampoo. On an unknown date in 2013, the pruritus resolved. On an unknown date in approximately May of 2013, the pruritus recurred. On an unknown date in approximately 2013, the dog was administered 1 tube of K9 Advantix II (unspecified) (imidicloprid-pyriproxifen-permethrin) topically by the owner. On an unknown date post product application, in approximately 2013, the pruritus resolved. No more information is expected. This case is closed. Follow up received on 02 Nov 2016: On approximately 01-Jan-2013, a neutered, female, Great Dane, of unknown age and weight, in good condition, with fleas, pruritus, and atopic allergies, bathed approximately every 3 days with a medicated pet shampoo in 2013, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date in 2013, the concomitant pruritus resolved. On an unknown date post application, in approximately May 2013, the pruritus recurred; the collar was removed. On an unknown date post onset, in approximately 2013, the dog was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Pyriproxyfen-Permethrin) topically by the owner. On an unknown date post product application, in approximately 2013, the pruritus resolved. On an unspecified date, in approximately 2014, the dog died. It is unknown if a necropsy was performed. The caller contacted Bayer animal heath to inquire about another pet and not to report this event. No further information is expected. Case is closed.
Mort
Pruritus was reported before application of product, therefore not related. Later reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very long time for reporting as the intent of the phone call to Bayer was to inquire about another pet and not to report this event. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/naphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Time to onset of serious sign (in minimum over 6 month) is much too long. Other etiologies more probable. Considering all aspects, product connection is deemed to be unlikely.